—#184574

Product

APEX Compounding System Control Panel Module, REF: 601238, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient.

FDA product code: NEP — System/Device, Pharmacy Compounding
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: All APEX Compounding System with Software Version 1.0.5.57 or earlier

Why it was recalled

There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy range for an individual ingredient.

Root cause (FDA determination)

Software change control

Action the firm took

On Nov. 23, 2020, the firm issued a "Urgent Medical Device Correction" letter to affected consignees via USPS mail. In addition to informing consignees about the recall device, the firm requested consignees take the following actions: 1. Review the URGENT MEDICAL DEVICE CORRECTION Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this voluntary Medical Device Correction and the affected product(s). 2. Ensure workflow(s) are in place to review air bubbles and scrap any final containers which exceed your facilitys guidelines until your APEX Compounding System has been upgraded to Software Version 1.0.5.58 or higher. " When compounding is complete, if bubbles were detected, APEX activates the Bubble Events button on the Compounding Complete screen allowing you to review the bubbles detected during compounding. " Until such time as your APEX software has been updated, BBMI recommends having qualified pharmacy personnel review this screen prior to removing the final container to ensure that the size of any air bubbles are within an allowable range per your facilitys guidelines. " Alternatively, your facility can have qualified personnel review each Compounding Activity Report generated by the device which also contains air bubble information. " Instructions for viewing the Bubble Events screen are provided in Attachment 02 of this Notice. Instructions for printing and reviewing the Compounding Activity Report are provided in Attachment 03 of this Notice. " Any final containers which exceed your facilitys allowable range should be scrapped. 3. Return the completed Acknowledgement Medical Device Correction form to BBMI by utilizing the enclosed self-addressed envelope or via scanned e-mail to BBMUS_Carrollton_QualitySystemManagement@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). It is important this form is

Recalling firm

Firm: B Braun Medical, Inc.
Address: 1601 Wallace Dr, Ste 150, Carrollton, Texas 75006-6690

Distribution

Distribution pattern: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, PA, TN,TX, WA.

Timeline

Recall initiated: 2020-11-23
Terminated: 2023-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184574. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.